Wearable auto-injector devices and methods

Abstract

Wearable auto-injector devices, systems and methods prevent medication administration in a device-worn state using a mechanism that prevents administration medication or by making it impossible or operationally impractical to physical orient or align the device to achieve injection. The device includes a housing, an attachment component enabling the housing to be worn by a user, and a medication delivery system including a needle and a medication reservoir. An advancement system advances the needle into a user's skin and causes the medication to flow through the needle. Various advancement systems, error-reduction mechanisms, attachment alternatives, and optional monitoring and communications capabilities are disclosed.

1 . A device for injecting a medication, comprising:
 a housing;   an attachment component enabling the housing to be worn by a user;   a medication delivery system disposed within the housing, the delivery system including a needle and a medication reservoir in fluid communication with the needle;   an advancement system disposed within the housing, the advancement system being operative to advance the needle through a user's skin and cause the medication to flow from the reservoir and through the needle for injection of the medication;   wherein the device transitions from a worn state, wherein the attachment component is fully secured to the housing, to an unworn state, wherein at least a portion of the attachment component is detached from the housing; and   wherein the medication cannot be administered in the worn state.   
     
     
         2 . The device of  claim 1 , wherein the medication is epinephrine. 
     
     
         3 . The device of  claim 1 , further including a mechanism disposed within the housing that prevents the medication from being administered in the worn state. 
     
     
         4 . The device of  claim 1 , wherein the device cannot be physically oriented for injection in the worn state. 
     
     
         5 . The device of  claim 1 , wherein the attachment component is a strap adapted to encircle a user's wrist or other body part. 
     
     
         6 . The device of  claim 1 , wherein component is unsecured by separating at least a portion of the attachment component from the housing. 
     
     
         7 . The device of  claim 1 , wherein the advancement system includes one or more compressed springs that are released to advance the needle or cause the medication to flow. 
     
     
         8 . The device of  claim 1 , wherein the advancement system uses a compressed gas to advance the needle and cause the medication to flow. 
     
     
         9 . The device of  claim 1 , wherein the advancement system includes a battery-operated motor or other electromechanical unit to advance the needle and cause the medication to flow. 
     
     
         10 . The device of  claim 1 , wherein the advancement system uses a multi-step activation sequence. 
     
     
         11 . The device of  claim 1 , wherein the advancement system is triggered by urging the device against tissue. 
     
     
         12 . The device of  claim 1 , wherein the advancement system is triggered by through a manual manipulation of the housing. 
     
     
         13 . The device of  claim 1 , further including at least one mechanism for preventing exposure of the needle until use. 
     
     
         14 . The device of  claim 13 , wherein the mechanism is a moveable shield. 
     
     
         15 . The device of  claim 13 , wherein the mechanism prevents exposure in the worn state. 
     
     
         16 . The device of  claim 1 , further comprising apparatus for limiting premature activation of the advancement system. 
     
     
         17 . The device of  claim 16 , wherein the apparatus for limiting premature activation of the advancement system is a manually operated mechanism. 
     
     
         18 . The device of  claim 16 , wherein the apparatus for limiting premature activation of the advancement system includes a sensor for detecting a specific condition; and
 further including a mechanism that prevents premature activation unless the specific condition is detected.   
     
     
         19 . The device of  claim 18 , wherein the specific condition includes one or more of the following:
 temperature,   proximity,   capacitance and   resistance.   
     
     
         20 . The device of  claim 1 , further comprising apparatus that places the device into a non-injectable state after activation of the advancement system. 
     
     
         21 . The device of  claim 1 , wherein the reservoir is refillable without removing the reservoir from the housing. 
     
     
         22 . The device of  claim 1 , wherein one or more of the following are replaceable:
 the needle;   the reservoir;   the advancement system; and   compressed gas.   
     
     
         23 . The device of  claim 1 , further comprising at least one indicator that informs a user as to an operational status of the device. 
     
     
         24 . The device of  claim 23 , wherein the operational status includes one or more of the following conditions:
 the device is in worn state;   the device is ready or primed for use;   the device is delivering medication; and   medication delivery complete.   
     
     
         25 . The device of  claim 23 , wherein the indicator is a visual, audible or tactile indicator. 
     
     
         26 . The device of  claim 1 , further comprising one or more of the following also disposed within the housing:
 a clock or other timekeeping element;   a heart-rate monitor;   pedometer;   pulsometer;   blood-pressure monitor;   electromyography (EMG) sensor;   Global Positioning System (GPS) sensor; and   a sensor operative to detect a biomarker.   
     
     
         27 . The device of  claim 1 , further comprising apparatus for wired or wireless communication with an external or remote device. 
     
     
         28 . The device of  claim 27 , wherein the wireless communication is performed using one or more of Bluetooth, RFID, near-field communication (NFC), and cellular communications. 
     
     
         29 . The device of  claim 1 , wherein the device is configured to perform one or more of the following functions:
 record sensor data, activation events or medication delivery events; and   communicate with emergency personnel when the device becomes ready for activation, delivers medication, or completes delivery of medication.   
     
     
         30 . The device of  claim 1 , wherein the device is configured to communicate with a smartphone to perform one or more of the following functions:
 record sensor data, activation events or medication delivery events; and   communicate with emergency personnel when the device becomes ready for activation, delivers medication, or completes delivery of medication.   
     
     
         31 . The device of  claim 1 , further comprising one or more visual, audible or tactile alerts to indicate if the medication will expire or become compromised due to environmental factors. 
     
     
         32 . The device of  claim 1 , wherein the attachment component is secured to an existing wearable accessory. 
     
     
         33 . The device of  claim 32 , wherein the wearable accessory is wrist, ankle or neck worn. 
     
     
         34 . The device of  claim 1 , wherein instructions for use of the device are located on the attachment component.